StockGuru Spotlight July 8, 2010

Published on July 8, 2010

StockGuru Spotlight – July 8, 2010

TNXI, NEPH, BTOW, VHGI, TAMO, PWSV, ITKG

Dear Members:

Many of the StockGuru Spotlight Picks are in a definitive upward trend. You have probably noticed StockGuru picks stocks that have had BAD NEWS. They have had the life kicked out of them and are probably trading much lower than they should. This represents a StockGuru Contrarian Pick.

In finance, a contrarian is one who attempts to profit by investing in a manner that differs from the standard trends, when the consensus opinion appears to be wrong. We are looking for exploitable mispricings. NEPH received a ‘rejection letter’ from the FDA as you will see in the press release below. However, you will see there has been a huge sell off plus they are going BACK to the FDA. Yesterday there was a huge ‘buy’ action in NEPH.

While you may not want to jump on the band wagon today — this is a perfect example of a ‘StockGuru Spotlight” to watch, closely.

That’s what StockGuru brings you every day: Trading News You Can Use. While you can never get the exact high trading the StockGuru way shows you the potential.

StockGuru Spotlight Pick Closer Look: NEPH hit $0.54 yesterday with volume close to 400K while the average volume since June 1 has been in the 84K range.

Something is happening here with NEPH. This is our StockGuru Spotlight Contrarian Pick — to watch TODAY! Stay with us while we follow this Company’s all important next few weeks.

Take a closer look at picks still trading close or near to their highs since StockGuru’s Original Pick Date.

StockGuru issues a press release for each of its picks and simultaneously posts that press release on its website. We do this so you can KNOW that StockGuru Picks are real.

We link you to those releases.

StockGuru brings you trading news you can use.

StockGuru Closer Look at OTCBB: NEPH

Nephros Receives Formal Response from FDA for 510(k) Application for Hemodiafiltration System

What I like about this Company is that they fully explain why they believe the have a chance at turning this around in this press release. Great release. Couple that with the activity yesterday and my focus is definitely here.

Nephros, Inc. (OTC Bulletin Board: NEPH) is a medical device company developing and marketing filtration products for therapeutic applications, infection control, and water purification. On July 7 the Company reported that the U.S. Food and Drug Administration has issued a formal response to the company’s 510(k) application.

On June 30, Nephros received a final decision letter from the FDA for the company’s 510(k) submission which stated that the FDA could not reach a substantial equivalence determination for the company’s hemodiafiltration (HDF) system.

“We are disappointed both by the FDA’s decision to reject our application and by the fact that the company was not provided an opportunity to address the current comments prior to a final decision being rendered,” said Paul A. Mieyal, acting CEO of Nephros. “After more than 15 months without a substantive communication, the company expected either an approval or further dialogue as the next step in the process. We feel that the issues raised in the current letter are addressable and have requested an in-person meeting with the review team to discuss options for moving forward.”

“Outside of the United States, hemodiafiltration is widely regarded by nephrologists as the gold standard therapy for dialysis patients. We are disappointed that the availability of HDF therapy in the U.S. has been further delayed,” commented Lawrence J. Centella, a member of Nephros’s Board of Directors and former Chief Operating Officer of Gambro Healthcare, Inc.

Next Steps

Nephros has requested an in-person meeting to discuss the issues raised in the current FDA letter as well as the process for moving forward.

Based upon the in-person meeting with the FDA reviewers, the company will determine the appropriate course of action, which could include filing a new 510(k) application or filing an appeal related to the current application.

Nephros has engaged King & Spalding LLP as regulatory counsel to advise the company in its next interactions with the FDA. The company also intends to utilize the FDA’s Ombudsman process.

Impact on Operations

The current decision by the U.S. FDA with regard to Nephros’s HDF system does not impact the ability of the company to market and sell its mid-dilution (MD) filters for hemodiafiltration procedures outside of the U.S.

The Nephros dual stage ultrafilter (DSU) received 510(k) marketing clearance from the FDA in 2009 to be used to filter biological contaminants from water and bicarbonate concentrate used in hemodialysis procedures. The 510(k) approval for the DSU filters is unrelated to the 510(k) application for the company’s HDF system.

Nephros continues to work with STERIS Corporation under the development agreement executed in March 2010.

Nephros is continuing the development of its dual stage ultra reliable personal water filtration system under support from its U.S. Department of Defense appropriation.

All of these are date and time stamped so you know what is current today. You can also just go to STOCKGURU.COM and look for the link in the top navigation for “StockGuru Spotlight.”

You can also put the RSS link into your RSS reader, such as my favorite “Google Reader.” There are countless programs that make it easy to get RSS feeds on your wireless phone as well. This is foolproof BUT ONLY IF YOU CHECK YOUR RSS FEED REGULARLY! RSS link on the site.

We do not yet send out Spotlight Alerts by email, in an attempt to give your email box a break. Spotlights occur several times weekly, and are released ONLY when we see a valid reason. Occasionally, our Spotlights are compensated picks, but an editorial decision is made as to whether the situation qualifies as a market sensitive pick.